Over the last few years, the requirements on the assessment of substances that could leach into the drug product over its life cycle have increased significantly. Substances may migrate from different materials and patients may be exposed through different routes of administration. on the other hand, A drug product container-closure system should not release chemicals that can accumulate in the drug product in quantities sufficient to present a risk of toxicity, or affect its stability or efficacy.
Join this workshop to embark on a journey through the pharmaceutical packaging testing. By attending you will be able to implement a successful strategy to ensure the safety of your products.
During this workshop you will learn:
- Regulatory Requirements and expectations on E&L
- How to Prepare a Successful E&L study
- Practical approaches for E&L testing
- Evaluation of E&L data
- Toxicological assessment
- E&L testing for single-use systems
- Container Closure Integrity Testing (CCIT)
About the workshop
DATE: 26th March 2025
TIME & LOCATION: 8:30 - 17:30 CET, B_Smart Hotel & Restaurant Schönenwerd, Oltnerstrasse 16, 5012, Schönenwerd
REGISTRATION FEE: FREE
WORKSHOP LANGUAGE: ENGLISH
SPEAKERS: Simone Carrara, Eleonora Lostaglio, Francesco Tessari, Francesca Calò, Daniele Zarini, Matilde Ciaroni
TOPICS:
- Study preparation
- Data evaluation
- Toxicological Assessment
- Extractables and Leachables Testing
- Container Closure Integrity Testing
- Regulatory Requirements
REGISTRATION FORM: https://form.jotform.com/250472478214356
CONTACT: BioPharma.Switzerland@bpt.eurofinseu.com
